Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030726486

FEI Number

3030726486

Entity Name

FRIDABABY, LLC

City/State/Country

Jacksonville, FL, US

Establishment Address

11007 Development Way, Jacksonville, FL 32220, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Fridababy, LLC (Owner Number: 10052488)

Owner / Operator Contact Address

82 NE 26th Street, Miami, FL 33137, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MediFrida the Accu-Dose Pacifier Frida Fertility Pee Collection Cup Frida Fertility Sperm Collection Cup Frida Mom Postpartum Abdominal Suport Binder C-Section Recovery Kit Frida mom Upside Down Peri Bottle frida mom Cooling Hydrogel Nipple Pads Not-Too-Cold-To-Hold Teether Ovulation and Pregnancy Test + Track Set Frida Fertility Early Detection Pregnancy Test Fridababy Training Toothbrush for Toddlers Fridababy Triple-Angle Toothhugger Fridababy Finger Toothbrush Fridababy Training Toothbrush for Babies Fridababy Grow-With-Me Training Toothbrush Set Baby Grooming Kit Smile Frida Kit Frida Mom C-Section Silicone Scar Patches Fridababy Windi the Gasspasser Fart Freeing Essentials Fridababy NoseFrida the Snotsucker Big Bundle of Joy Sick Day Prep Kit Bitty Bundle of Joy Fridababy NoseFrida The Snotsucker Saline Kit Baby Basics Kit Fridababy Electric NoseFrida Ultimate Baby Kit NoseFrida Hygiene Filters NoseFrida Saline Mist Inhaler Postpartum Catch-All Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-04-30
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-01-04
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2021-12-27
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2021-11-30
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2023-06-20
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2023-11-08
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-04-06
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2023-04-06
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-11-18
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2021-12-27
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2020-02-05
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-07-20
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2024-06-24
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2022-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fridababy, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005833605	Nasalprodukter Sverige AB	Malmo Skane, SE
3005630901	FridaBaby LLC	Miami, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030726486. Last updated year: 2026. Please use registration number 3030726486 when referencing this establishment in official correspondence.